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United States Patent |
5,032,408
|
Schreuder
|
July 16, 1991
|
Composition for treatment of skin affections and process for its
preparation
Abstract
The invention is directed to a composition of skin disorders, such as
cellulites or striae, comprising
an oily fraction of paraffinic oils,
an emulsifier, predominantly consisting of
a) mono- and/or diglycerides of higher unsaturated natural fatty acids, and
b) ethoxylated glycerides esterified with fatty acids,
pancreas extract and/or thymus extract derived from pancreas and/or thymus
tissue as such or from previously partially hydrolized pancreased and/or
thymus tissue,
stabilizer consisting of montmorillonites, the free oxygen sites of which
have been covered with quaternary groups,
a preservative consisting of esters of p-hydroxybenzoic acid and/or
substituted imidazolidinyl urea derivatives, and
water.
Inventors:
|
Schreuder; J. C. P. (Baarn, NL)
|
Assignee:
|
Chemisch Adviesburea Drs. J.C.P. Schruder (Baarn, NL)
|
Appl. No.:
|
865266 |
Filed:
|
May 20, 1986 |
Foreign Application Priority Data
| May 28, 1985[EP] | 85106526.8 |
Current U.S. Class: |
424/556; 424/580; 424/776; 514/474; 514/558 |
Intern'l Class: |
A61K 035/39; A61K 035/28; A61K 035/78 |
Field of Search: |
424/95,110,195.1,580,556
514/558,861,863,864,474
|
References Cited
U.S. Patent Documents
2153653 | Apr., 1939 | Stux | 424/195.
|
4263284 | Apr., 1981 | Schreuder | 424/180.
|
4369180 | Jan., 1983 | Mihalovits | 424/195.
|
4446051 | May., 1984 | Berthod et al. | 252/309.
|
4522807 | Jun., 1985 | Kaplan | 424/59.
|
4783332 | Nov., 1988 | Schreuder | 424/63.
|
Foreign Patent Documents |
0007120 | Jan., 1980 | EP.
| |
0048153 | Mar., 1982 | EP.
| |
0158090 | Oct., 1985 | EP.
| |
2504551 | Oct., 1982 | FR | 424/195.
|
2530466 | Jan., 1984 | FR | 424/95.
|
0064909 | Apr., 1985 | JP | 424/110.
|
1091133 | May., 1986 | JP | 424/110.
|
0644481 | Jan., 1979 | SU | 424/110.
|
Other References
Richand, Chem. Abs. 80, 74270m, 1974.
Thuillier et al., Chem. Abs., 83, 33021z, 1975.
Webster's Ninth New Collegiate Dictionary, p. 219 (1986).
The Merck Manual of Diagnosis and Therapy, pp. 49-51 (1987).
|
Primary Examiner: Rollins; John W.
Attorney, Agent or Firm: Bierman and Muserlian
Claims
I claim:
1. Process for the preparation of a composition for the treatment of skin
disorders consisting essentially of a continuous oily fraction consisting
of branched or unbranched paraffinic oils containing 10 to 30 carbon atoms
in the amount of 5% to 50% by weight, calculated on the weight of the
complete composition and unmixed or mixed with esters of unsaturated
higher natural fatty acids and higher natural unsaturated aliphatic IN THE
alcohols both containing at most 20 carbon atoms, an emulsifier composed
of a) at least one member of the group consisting of mono- and
diglycerides of higher unsaturated natural fatty acids, unmixed or mixed
with the esters derived from saturated higher natural fatty acids, in an
amount of 1% to 10% by weight, calculated on the weight of the complete
composition, and b) ethoxylated glycerides esterified with fatty acids of
the formula
##STR2##
wherein n represents an integer from 5 to 20, R represents a saturated or
unsaturated fatty acid residue derived from at least one member of the
group consisting of animal and vegetable oils, and R may represent the
same or different fatty acid residues in one molecule, whereby the ratio
between the amount of mono- and diglycerides and the amount of ethoxylated
triglycerides may vary from 10 to 100 parts of mono- and diglycerides per
part of ethoxylated triglyceride, and whereby the amount of the emulsifier
system, calculated on the weight of the complete composition may vary from
1% to 10% by weight, at least one member of the group consisting of
pancreas extract and thymus extract derived from pancreas and thymus
tissue and from previously partially hydrolyzed pancreas and thymus
tissue, in an amount of 0.05% to 5% by weight of pancreas dry matter
material and an amount of 0.01% to 5% by weight of thymus dry matter
material, calculated on the weight of the complete composition, stabilizer
consisting of montmorillonites, the free oxygen sites of which have been
covered with quaternary groups, in an amount of 0.2% to 4% by weight,
calculated on the weight of the complete composition, a preservative being
at least one member of the group consisting of esters of para
hydroxybenzoic acid and substituted imidazolidinyl urea derivatives in an
amount of 0.05% to 1% by weight, calculated on the weight of the complete
composition and water to make up 100% by weight based on the weight of the
entire composition characterized in that an oily phase is prepared by
addition of the emulsifier, preservative and stabilizer to the oil
components under stirring and heating and gelating after addition of
alcohol, followed by cooling to 30.degree. C. or lower and followed by
addition of an aqueous phase prepared by stirring in water, the following
ingredients glycerol, pancreas extract, the carraghenate, citric acid and
vitamin C, optional buffer at a temperature of at most 30.degree. C.
followed by addition under stirring perfume and camomile extract, until an
average particle size of at most 5.mu. is reached.
2. A method of treating a skin disorder of a person comprising applying to
the skin of a person with a skin disorder an amount of a composition for
the treatment of skin disorders consisting essentially of a continuous
oily fraction consisting of branched or unbranched paraffinic oils
containing 10 to 30 carbon atoms in the amount of 5% to 50% by weight,
calculated on the weight of the complete composition and unmixed or mixed
with esters of unsaturated higher natural fatty acids and higher natural
unsaturated aliphatic alcohols both containing at most 20 carbon atoms, an
emulsifier composed of a) at least one member of the group consisting of
mono- and diglycerides of higher unsaturated natural fatty acids, unmixed
or mixed with the esters derived from saturated higher natural fatty
acids, in an amount of 1% to 10% by weight, calculated on the weight of
the complete composition, b) ethoxylated glycerides esterified with fatty
acids of the formula
##STR3##
wherein n represents an integer from 5 to 20, R represents a saturated or
unsaturated fatty acid residue derived from at least one member of the
group consisting of animal and vegetable oils, and R may represent the
same or different fatty acid residues in one molecule, whereby the ratio
between the amount of mono- and diglycerides and the amount of ethoxylated
triglycerides may vary from 10 to 100 parts of mono- and diglycerides per
part of ethoxylated triglyceride, and whereby the amount of the emulsifier
system, calculated on the weight of the complete composition may vary from
1% to 10% by weight, at least one member of the group consisting of
pancreas extract and thymus extract derived from pancreas and thymus
tissue and from previously partially hydrolyzed pancreas and thymus
tissue, in an amount of 0.05% to 5% by weight of pancreas dry matter
material and an amount of 0.01% to 5% by weight of thymus dry matter
material, calculated on the weight of the complete composition, stabilizer
consisting of montmorillonites, the free oxygen sites of which have been
covered with quaternary groups, in an amount of 0.2% to 4% by weight,
calculated on the weight of the complete composition, a preservative being
at least one member of the group consisting of esters of para
hydroxybenzoic acid and substituted imidazolidinyl urea derivatives in an
amount of 0.05% to 1% by weight, calculated on the weight of the complete
composition and water to make up 100% by weight based on the weight of the
entire composition sufficient to treat the skin disorder.
3. The method of claim 2 wherein the skin disorder is cellulites or striae.
4. Method of claim 2, characterized in that it contains an oily fraction in
an amount of 10-30% by weight of the composition.
5. Method of claim 2, characterized in that it is composed of an oily
fraction, mixed with oleyl oleate or oleyl decalate, in an amount of 2-5%
by weight, calculated on the weight of the composition of the complete
composition.
6. Method of claim 2, characterized in that the emulsifier is composed of
ethoxylated triglycerides and of mono- or diglycerides of mixtures thereof
derived from linoleic acid, oleic acid, linolenic acid, or mixtures
thereof, mixed with mono- or diglycerides or mixtures thereof derived from
palmitic acid, or lauric acid, myristic acid, stearic acid or mixtures
thereof.
7. Method of claim 2, characterized in that the ratio of mono- or
diglycerides or mixtures thereof to the ethoxylated triglycerides is 25
parts per part ethoxylated triglycerides.
8. Method of claim 2, characterized in that preservative in the oily phase,
one or more esters of p-hydroxybenzoic acid are applied in an amount of
0.2-0.4% by weight.
9. Method of claim 2, characterized in that preservative in the aqueous
phase imidazolidinyl urea derivatives are applied in an amount of 0.2-0.4%
by weight.
10. Method of claim 2, characterized in that the pH of the complete
composition is between 5.5 and 7.5.
Description
The invention is relating to a composition for the treatment of skin
affections and more particularly to a composition for treatment of so
called skin disorders such as cellulitis or striae which affections seem
both to be caused by a disturbed metabolism in the derm and usually
manifest by means of an irregular shape of the epidermis and/or striking
concentration of fatty tissue due to the absence or the destroyed state of
connective tissue.
The invention is more relating to the application of such a composition for
the fight against the beforementioned symptom and to a process for the
preparation of such composition.
Already several means and compositions were proposed in the past for
avoidance of such skin affections. However, with the formerly proposed
means the prevention of the beforementioned symptoms could not be
attained. Therefore there is a still growing need for compositions for an
efficient and quick treatment of the beforementioned skin disorders.
Surprisingly there could be found, as result of extensive research and
experimentation, an adequate composition, which comprises at least the
following ingredients: an oily fraction, consisting of optionally branched
paraffinic oils containing 10-30 carbon atoms and preferably 12-25 carbon
atoms in their chain, in an amount of 5-50% by weight and preferably by
10-30% by weight, calculated on the weight of the complete composition.
The paraffinic oils have a boiling range of between 100.degree. and
500.degree. C. and show a viscosity of up to 35 centistokes at 25.degree.
C.
These paraffinic oils may optionally be mixed with esters from
predominantly unsaturated higher natural fatty acids and from higher
natural unsaturated aliphatic alcohols containing at most 20 carbon atoms,
such as oleyl oleate or oleyl decalate (e.g. Cetiol V.RTM.).
By the term "higher natural fatty acids" and "higher natural" alcohols is
meant fatty acids and alcohols, which may be derived from products
occuring in nature, such as animal or vegetable oils and fats such as
linseed oil, sunflower oil, rape-seed oil, whale oil, perilla seed oil,
tung oil, castor oil.
It has appeared that for the most effective compositions, these esters have
to be added to the paraffinic oil fraction in an amount of 1-6% by weight
and preferably 2-5% by weight, calculated on the weight of the complete
composition. an emulsifier, predominantly composed by
a) mono- and/or diglycerides of higher unsaturated natural fatty acids,
such as linoleic acid, oleic acid, linolenic acid, eleostearic acid,
licanic acid, ricinoleic acid, petroselinic acid, vaccenic acid,
arachidonic acid, cetoleic acid, erucic acid, selacholeic acid or
palmitoleic acid or mixtures thereof, optionally mixed with those, derived
from saturated higher natural fatty acids such as palmitic acid, lauric
acid, myristic acid, stearic acid or mixtures thereof (e.g. Tegomuls.RTM.)
in an amount of 1-10% by weight and preferably 2-8% by weight, calculated
on the weight of the complete composition, and
b) ethoxylated glycerides, esterified with fatty acids according to the
general formula:
##STR1##
wherein n represents an integer from 5 to 20 and preferably 7-15, wherein
R represents a saturated or unsaturated and preferably unsaturated fatty
acid residue, derived from animal and/or vegetable oils, while R may
represent the same or different fatty acid residues in one molecule but
preferably the same residue (e.g. Tagat TO .RTM.).
In contradistinction to a large number of systems of a different kind which
were empirically tried for this purpose, the beforementioned emulsifier
system surprisingly appeared to meet the requirement, that not too large
amounts are used of the inevitably to be applied emulsifiers with
reference to skin affections on the one hand, as relatively small amounts
of this emulsifier system appeared to be necessary as compared with the
presently proposed emulsifier system may be regarded according to the
experience as extremely skin friendly which feature is related to a
relatively low hydrophilic-lipophilic balance value.
The ratio between the amount of mono- and/or diglycerides on the one hand
and the ethoxylated triglycerides on the other hand may vary, while the
attractive activity is maintained, from 10-100 parts of mono- and/or
diglycerides pro part of ethoxylated triglycerides and preferably 25 parts
of mono- and/or diglycerides pro part of ethoxylated triglycerides. The
total amount of the beforementioned emulsifier system, calculated on the
weight of the complete composition may vary from 1-10% by weight and
preferably from 2-8% by weight for the most attractive results. pancreas
and/or thymus extract derived from pancreas and/or thymus tissue as such
or from previously partially hydrolyzed pancreas and/or thymus tissue and
more particular from bovine pancreas and/or thymus. The pancreas extract
to be applied is used in an amount of 3-5% by weight as dry matter based
on the weight of the total composition and preferably used as a standard
solution containing 10% by weight of pancreas dry matter (e.g.
Revitalin.RTM.). Such a standard solution is added in an amount to give
0.05-5% by weight of pancreas dry matter material calculated on the weight
of the complete composition and more preferably in an amount of 0.1-2% by
weight.
The thymus extract is applied in an amount of 0.01-5% as dry matter based
on the weight of the total composition and preferably used as a standard
solution containing 2,5-4% by weight of dry matter and preferably 3-3,5%
of thymus dry matter in the form of thymus hydrolysate (peptide). a
stabilizer, consisting of montmorillonites, the free oxygen sites of which
have been covered with quaternary groups.
Examples of such systems, which are preferably applied, are e.g. the so
called Bentone.RTM. and Propoloid.RTM. preparations, which are added in an
amount of 0.2-4% by weight and preferably of 0.5-2% by weight, calculated
on the weight of the complete composition.
In the compositions containing the beforementioned stabilizers surprisingly
no significant sagging occurs of one or more of the composing ingredients
and particularly not in the relatively low viscous systems, which are
preferred for practical reasons. a preservative. Preferably different
types of preservatives are applied for the contineous oily phase and the
dispersed aqueous phase. For instance an ester of parahydroxy benzoic acid
and preferably the methyl and/or the propyl and/or butyl ester in an
amount of from 0.05-1% by weight, calculated on the weight of the complete
composition and preferably in an amount of from 0.2-0.4% by weight are to
be applied in the oily phase. Preferably mixtures of methyl-, propyl- and
butyl-p-hydroxybenzoate are applied (e.g. Phenonip.RTM.).
These beforementioned preservatives may be replaced in total or partially
by other preservatives primarily consisting of imidazolidinyl urea
derivatives (e.g. Euxyl.RTM. or Hydroconserv.RTM.) in an amount of from
0.05-1% by weight and preferably 0.2-0.4% by weight in the dispersed
aqueous phase. water, ad 100% by weight, calculated on the weight of the
complete composition.
In addition to the hereinbefore mentioned primary basic ingredients, one or
more secondary ingredients may be added if desired, such as vitamin E as
such or more preferably in the relatively stable acetate form, in an
amount of 0.05-5% by weight based on the weight of the complete
composition and more preferably in an amount of 0.2-2% by weight. glycerol
as stabilizer of the emulsion, in an amount of 0.5-5.0% by weight
calculated on the weight of the complete composition, and preferably in an
amount of 1-3% by weight. carraghenate, in an amount of from 0.1 to 5% by
weight, calculated on the weight of the complete composition and
preferably in an amount of from 0.5-2% by weight.
The carraghenate, like e.g. Aubygum X.RTM., is preferably consisting of a
polysaccharide bearing sulfonic acid residues, being of natural origin
such as those derived from sea weeds. The sulfonic acid residues
optionally have been converted into salts or esters e.g. sodium salt or
ester from glycol, propylene glycol and glycerol (so called modified
carraghenates).
Such carraghenates have empirically appeared to effect a surprisingly
attractive stabilizing effect of the complete composition to be applied on
the skin, while as additional advantageous effect, the known attractive
properties of such carraghenates, such as elimination of an eventual
hardening of tissue, appeared to be maintain in the final complete system.
The hereinbefore mentioned amounts of carraghenate cause in the final
composition a gel structure with a viscosity of from 200-5000 centipoises
which is desired for an adequate application.
It will be appreciated by a person skilled in the art of this specific
area, that the carraghenate possibly may partially be replaced by
alternative gel forming means such as carboxymethylcellulose esterified
polyacrylic acid (such as Carbopol.RTM.), hydroxy ethyl cellulose, in an
amount which leads to a viscosity of the final composition in the same
desired, hereinbefore mentioned specified range. perfume in an amount of
from 0.1-0.5% by weight and preferably in an amount of 0.2% by weight,
calculated on the amount of the total composition, an antioxydant in an
amount of from 0.01-0.3% by weight and preferably in an amount of 0.1% by
weight, calculated on the weight of the total composition. citric acid and
optionally vitamin C, in an amount of 0.1-5% by weight calculated on the
weight of the total composition and preferably in such an amount to give a
pH of the total composition of a value from 5-8 and more particularly a
normal pH of the outer skinlayers of from 5.5-7.5. It will be appreciated
that the citric acid and/or vitamin C have to be added in the form of a
buffer system, i.e. in partially neutralized form. alcohol (96%) in an
amount of 0.1-1.0% by weight and preferably of 0.3-0.6% by weight,
calculated on the weight of the total composition. The alcohol may be
added for a fast gelation of the quaternary montmorillonites and
preferably in an amount being the half of the amount of montmorillonites.
camomile extract for giving the final composition the desired colour, in
an amount of 0.01-0.5% by weight and preferably of 0.05-0.1% by weight,
calculated on the weight of the complete composition (e.g. Azuleen.RTM.).
The present compositions are characterized in a relatively low viscosity
and high stability and a fast curing of the beforementioned skin
affections.
The compositions according to the present invention may be prepared
according to a process, which forms another feature of this invention, the
sequence of the addition and the rate of dosage of the respective
components and the temperature of which have appeared to be important.
According to this process in a first step the complete continuous oily
phase is prepared, composed by respectively the oil fractions, the esters
of unsaturated fatty acids and alcohols, emulsifiers, stabilizers,
preservatives and alcohol, while the dispersed aqueous phase is composed
by water, glycerol, pancreas extract, the carraghenate, citric acid and/or
vitamin C. The vitamin E and camomile extract and perfume may be added to
the prepared emulsion.
The final compositions of the present invention are preferably prepared by
preparing and mixing the both phases at a temperature of at most
30.degree. C., while adding of vitamin E, camomile extract and perfume and
homogenizing the mixture.
The emulsion is additionally stirred and homogenized until an average size
of the dispersed particles of at most 5.mu. and preferably<3.mu. is
reached.
It will be appreciated, that the process is characterized in a significant
simplicity, which means a saving of labour and/or energy and therefore
leads to lowered costs.
It will be appreciated that the treatment of the beforementioned skin
disorders with the present compositions has to be regarded as one of the
features of the invention.
Such a treatment is carried out in a way, usual for such compositions and
is more particularly carried out by a process, characterized in that an
amount of 2-5 ml is applied on the skin area involved and is spread
evenly, optionally after thorough and careful cleaning of the skin with
water and soap and/or an alcoholic solution.
This treatment has preferably to be carried out 2-3 times a day.
An additional advantage of such a treatment is caused by the fact that the
skin area involved is not greasy rather immediately after treatment due to
a fast penetration of the composition into the skin tissue. Therefore
smudges in clothes or bed-linen may be avoided.
The invention is illustrated on basis of the subsequent examples, however
without restricting the scope of it thereto:
EXAMPLE 1
Under stirring the following ingredients are combined:
__________________________________________________________________________
paraffinic oil (I) 130
g.
(Shell Ondina 15 .RTM. , boiling range 295-390.degree. C.)
paraffinic oil II 30 g.
(Shell Ondina 68 .RTM. , boiling range 290-500.degree. C.)
mono- and/or diglycerides (Tegomuls .RTM. )
25 g.
oleyl decalate (Cetiol V .RTM. )
30 g.
ethoxylated triglycerides (Tagat TO .RTM. )
1 g. oily phase
preservative I (Phenonip .RTM. )
2 g.
followed by addition of
quaternary modified montmorillonites (Bentone 38 .RTM. )
6 g.
and gelation by
addition of alcohol (96%) 3 g.
The mixture is cooled to at most 30.degree. C.
In water (632.5 g.) are subsequently dissolved:
preservative II (Euxyl 100 .RTM. )
3 g.
glycerol 20 g.
pancreas extract (Revitalin .RTM. solution
100
g. aqueous phase
containing 10% by weight dry matter)
carraghenate (Aubygum X2 .RTM. )
5 g.
__________________________________________________________________________
giving an aqueous phase, which is subsequently mixed with the obtained oily
phase and homogenized after addition of vitamin E (10 g.), camomile
extract (0.5 g) and perfume (2 g.)
The obtained emulsion is further homogenized until an average particle
size<3.mu. is reached.
EXAMPLE 2
In the same way as described under example 1, a composition is prepared
from the following ingredients:
__________________________________________________________________________
paraffinic oil I 125
g.
paraffinic oil II 30 g.
mono- and/or diglycerides 16 g.
oleyloleate 26 g.
ethoxylated triglycerides 1 g. oily phase
preservative I 2 g.
quaternary modified montmorillonites (Bentone 38 .RTM. )
6 g.
alcohol (96%) 3 g.
and
water 610
g.
glycerol 15 g.
pancreas extract (Revitalin .RTM. , 10% solution)
150
g. aqueous phase
preservative II 3 g.
carraghenate (Aubygum X2 .RTM. )
6 g.
and
perfume 1 g.
vitamin E (acetate) 5 g.
camomile extract (azuleen)
1 g.
__________________________________________________________________________
EXAMPLE 3
In the same way as defined in example 1, a composition was prepared from
the following ingredients:
______________________________________
paraffinic oil I 160 g.
paraffinic oil II 35 g.
mono- and/or diglycerides
25 g.
oleyldecalate 26 g.
ethoxylated triglycerides
2 g. oily phase
preservative I 2 g.
quaternary modified montmorillonites
7 g.
alcohol (96%) 3 g.
and
water 510 g.
citric acid buffer, corresponding with
10 g.
citric acid
pancreas extract (Revitalin .RTM. , 10%
200 g. aqueous
sol.) phase
preservative III (Hydroconserv .RTM. )
3 g.
carraghenate (Aubygum X2 .RTM. )
10 g.
and
perfume 1 g.
vitamin E (acetate) 5 g.
camomile extract (azuleen)
1 g.
______________________________________
EXAMPLE 4
In the same way as described in example 1, a composition was prepared from
the following ingredients:
______________________________________
paraffinic oil I 140 g.
paraffinic oil II 25 g.
mono- and/or diglycerides
15 g.
oleyldecalate 26 g.
ethoxylated triglycerides
0.5 g. oily phase
preservative I 3 g.
quaternary modified montmorillonites
7 g.
alcohol (96%) 3 g.
and
water 500.5 g.
vitamin C and citric acid in a buffer
15 g.
form)
glycerol 20 g. aqueous
pancreas extract (Revitalon .RTM. , 10%
200 g. phase
sol.)
preservative III 3 g.
carraghenate (Aubygum X2 .RTM. )
15 g.
and
perfume 1 g.
vitamin E (acetate) 25 g.
camomile extract 1 g.
______________________________________
EXAMPLE 5
In the same way as described in example 1, a composition was prepared from
the following ingredients:
______________________________________
paraffinic oil I 130 g.
paraffinic oil II 30 g.
mono- and/or diglycerides
25 g.
oleyl decalate 30 g.
ethoxylated triglycerides
1 g. oily phase
preservative I 3 g.
quaternary modified montmorillonites
7 g.
alcohol (96%) 3 g.
and
water 666 g.
citric acid in a buffer form
15 g.
glycerol 20 g. aqueous
thymus extract (3% solution)
35 g. phase
preservative II 3 g.
carraghenate 15 g.
and
perfume 1 g.
vitamine E (acetate)
15 g.
camomile extract 1 g.
______________________________________
EXAMPLE 6
In the same way as described in example 1, a composition was prepared from
the following ingredients:
______________________________________
paraffinic oil I 130 g.
paraffinic oil II 30 g.
mono- and/or diglycerides
25 g.
oleyl decalate 30 g.
ethoxylated triglycerides
1 g. oily phase
preservative I 3 g.
quaternary modified montmorillonites
7 g.
alcohol (96%) 3 g.
and
water 656 g.
vitamin C and citric acid in a buffer
15 g.
form) aqueous
glycerol 18 g. phase
thymus extract (3% solution)
15 g.
pancreas extract (10% solution)
50 g.
and
perfume 1 g.
vitamin E 15 g.
camomile extract 1 g.
______________________________________
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